Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca, alongside Scientific American Custom Media, announced the winners of the 2021 Cancer Community Awards (C2 Awards). This year, a new Catalyst for Equity Award was introduced to support health equity for disadvantaged communities. Over 100 nominations were received from 28 states. Winners received a $50,000 donation for a nonprofit organization. The awards recognize individuals and organizations making significant contributions in oncology, aiming to enhance cancer care and ensure equitable access to treatments.

Positive results from the HIMALAYA Phase III trial indicated that a single dose of tremelimumab alongside IMFINZI yielded significant overall survival benefits compared to sorafenib for patients with unresectable hepatocellular carcinoma (HCC). The combination therapy, named the STRIDE regimen, also showcased a favorable safety profile, with no increase in severe hepatic toxicity. IMFINZI alone showed non-inferior overall survival against sorafenib, trending favorably with improved tolerability. The study involved 1,324 patients across 190 centers worldwide.

AstraZeneca has received Orphan Drug Designation from the FDA for Tezepelumab to treat eosinophilic esophagitis (EoE), a rare inflammatory disease affecting the esophagus. This designation is crucial as it supports the development of therapies for diseases impacting fewer than 200,000 patients in the U.S. Currently, no FDA-approved treatments exist for EoE. Tezepelumab is also under Priority Review for asthma in the U.S., with decisions anticipated in early 2022. The collaboration between AstraZeneca and Amgen continues, enabling joint commercialization efforts.

AstraZeneca has filed for Emergency Use Authorization (EUA) with the US FDA for AZD7442, a long-acting antibody combination to prevent symptomatic COVID-19. The drug shows a 77% reduction in risk based on data from the PROVENT Phase III trial. This submission marks a significant step as AZD7442 could be the first long-acting antibody approved for COVID-19 prevention. The trial included participants with comorbidities, with over 75% at increased risk. AZD7442 leverages proprietary technology to enhance its durability, potentially offering up to 12 months of protection.

The FDA has granted ENHERTU Breakthrough Therapy Designation for treating adult patients with unresectable or metastatic HER2-positive breast cancer. This designation is based on the DESTINY-Breast03 trial, showing a 72% reduction in disease progression or death compared to T-DM1. ENHERTU now holds four BTDs, with the total patient survival rate at one year reaching 94.1%. The designation aims to expedite development for medicines addressing significant unmet medical needs. The ongoing comprehensive clinical program assesses ENHERTU across various HER2-targetable cancers.

Compugen Ltd. (NASDAQ: CGEN) announced a $6 million milestone payment from AstraZeneca (NASDAQ: AZN) following the first patient dosing in a Phase 1/2 study of AZD2936, a TIGIT/PD-1 bispecific antibody for lung cancer. This event marks the advancement of Compugen's COM902 program into clinical trials, contributing to its pipeline expansion. To date, Compugen has received a total of $12 million from AstraZeneca under their 2018 license agreement, which could potentially yield up to $200 million in milestone payments and royalties on sales.

On World Heart Day, the AstraZeneca HealthCare Foundation awarded $954,311 in grants to seven nonprofit organizations across the US to combat cardiovascular disease. This initiative is part of the Connections for Cardiovascular Health program aiming to enhance heart health among underserved communities. Since 2010, the Foundation has allocated over $25 million to various projects, impacting over 1.7 million individuals. The grant recipients include organizations addressing health screening, nutrition education, and access to healthcare services.

AstraZeneca will present data on its COVID-19 and RSV pipeline at the IDWeek 2021 conference, showcasing the long-acting antibody AZD7442 and its potential for COVID-19 prevention. Phase III PROVENT trial results indicate AZD7442 may reduce symptomatic COVID-19 risk significantly, particularly in vulnerable populations. The analysis will also cover the efficacy of AZD1222 in preventing asymptomatic infections and the recently developed nirsevimab for RSV protection in infants. Preliminary findings suggest that AZD7442 neutralizes emerging SARS-CoV-2 variants and regulatory submissions for emergency use authorization are forthcoming.

AstraZeneca and Merck have announced promising results from the PROpel Phase III trial of LYNPARZA® (olaparib) combined with abiraterone in treating men with metastatic castration-resistant prostate cancer (mCRPC). The trial demonstrated statistically significant improvement in radiographic progression-free survival (rPFS) compared to standard treatment. Although there was a trend towards better overall survival, further assessment is needed. The findings offer hope for new treatment options for patients with limited choices.